Johner Institute
Business Consulting and ServicesBaden-württemberg, Germany51-200 Employees
Johner Institute is a mid-sized professional services firm based in Konstanz, in the Baden-Württemberg region of Germany, serving the medical device sector. It helps manufacturers compile, review, and enhance their technical documentation, spanning risk management, usability, software documentation, and clinical evaluations, with attention to artificial intelligence considerations. The organization also assists in establishing, auditing, and improving quality management systems to align with ISO 13485 and related regulatory requirements, and it conducts usability testing in Europe and the United States. Its clients are medical device manufacturers seeking regulatory compliance and lifecycle safety, including post-market surveillance and regulatory affairs updates. The firm positions itself as an international partner in the regulatory and quality assurance landscape, with capabilities that span Europe and the United States.
1-888-653-2347 
support@leadiq.com 
